FDA Product Code
FDA Product Code HIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1730
510(k) Clearances — 179 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | 2026-08-19 | Traditional | PDF ↗ |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology , Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | 2025-09-22 | Traditional | PDF ↗ |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | 2025-04-11 | Traditional | PDF ↗ |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | 2025-01-13 | Traditional | PDF ↗ |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024-10-15 | Traditional | PDF ↗ |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024-05-02 | Traditional | PDF ↗ |
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024-05-02 | Traditional | PDF ↗ |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024-01-12 | Traditional | PDF ↗ |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | 2023-12-14 | Traditional | PDF ↗ |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | 2023-09-20 | Traditional | PDF ↗ |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 | Traditional | PDF ↗ |
| K231407 | StarFin | Premium Medical Technology, LLC | 2023-08-29 | Traditional | PDF ↗ |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 | Traditional | PDF ↗ |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 | Traditional | PDF ↗ |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 | Traditional | PDF ↗ |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | 2022-02-23 | Traditional | PDF ↗ |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | Conmed Corporation | 2021-08-19 | Traditional | PDF ↗ |
| K202799 | EVA15 | Palliare , Ltd. | 2020-10-21 | Special | PDF ↗ |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2020-07-29 | Traditional | PDF ↗ |
| K193520 | EVA 15 Insufflator | Palliare , Ltd. | 2020-07-23 | Traditional | PDF ↗ |
| K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-01-30 | Traditional | PDF ↗ |
| K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2019-08-28 | Traditional | PDF ↗ |
| K190303 | AirSeal | Conmed Corporation | 2019-03-28 | Traditional | PDF ↗ |
| K172835 | GRI-Alleset Veress Needle | Gri Medical and Electronic Technology Co., Ltd. | 2018-06-11 | Traditional | PDF ↗ |
| K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | 2018-03-16 | Traditional | PDF ↗ |
| K173545 | TEMED Gas Diffuser | Temed | 2018-02-14 | Traditional | PDF ↗ |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017-11-14 | Traditional | PDF ↗ |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare | 2017-06-23 | Traditional | PDF ↗ |
| K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | 2017-05-18 | Traditional | PDF ↗ |
| K170784 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2017-05-15 | Traditional | PDF ↗ |
| K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | KARL STORZ Endoscopy-America, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K162648 | U-Blade Veress Needle | Tianjin Uwell Medical Device Manufacturing Co., Ltd. | 2016-12-12 | Traditional | PDF ↗ |
| K153367 | S698 Symbioz flow | Sopro - Acteon Group | 2016-06-17 | Traditional | PDF ↗ |
| K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016-03-04 | Traditional | PDF ↗ |
| K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-07-31 | Traditional | PDF ↗ |
| K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K142700 | InsufflatOR Needle | Gynetech Pty. , Ltd. | 2014-12-19 | Traditional | PDF ↗ |
| K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | Lexion Medical, LLC | 2014-03-05 | Special | PDF ↗ |
| K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | Lexion Medical, LLC | 2013-09-20 | Traditional | PDF ↗ |
| K132204 | INSUFLOW SYNERGY XL PORT | Lexion Medical, LLC | 2013-08-22 | Special | PDF ↗ |
| K122180 | HIGH FLOW INSUFFLANTION UNIT | Olympus Medical Systems Corporation | 2012-11-13 | Traditional | PDF ↗ |
| K120151 | NEBULAE I | Northgate Technologies, Inc. | 2012-08-17 | Traditional | PDF ↗ |
| K120640 | INSUFLOW SYNERGY PORT | Lexion Medical, LLC | 2012-07-18 | Traditional | PDF ↗ |
| K121336 | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | Surgiquest, Inc. | 2012-07-03 | Special | PDF ↗ |
| K112975 | CARBONAID C02 DIFFUSER | Cardia Innovation AB | 2012-06-22 | Traditional | PDF ↗ |
| K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 | Olympus Medical Systems Corporation | 2011-11-18 | Traditional | PDF ↗ |
| K111955 | MEDLINE PNEUMOPERITONEUM NEEDLE | Medline Industries, Inc. | 2011-11-16 | Traditional | PDF ↗ |
| K112357 | VESSEL GUARDIAN | Lexion Medical, LLC | 2011-11-10 | Traditional | PDF ↗ |
| K111441 | UNIMAX VERESS NEEDLE | Unimax Medical Systems, Inc. | 2011-08-19 | Traditional | PDF ↗ |
| K103692 | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 | Surgiquest, Inc. | 2011-05-25 | Traditional | PDF ↗ |
| K102136 | VESSEL GUARDIAN | Lexion Medical, LLC | 2010-09-27 | Traditional | PDF ↗ |
| K101320 | VASOVAPOR | Lexion Medical, LLC | 2010-06-24 | Traditional | PDF ↗ |
| K090652 | ALPHA DUO LAP INSUFFLATOR | Hippokratec GmbH | 2009-09-25 | Traditional | PDF ↗ |
| K091366 | INSUFLOW DEWHEART | Lexion Medical, LLC | 2009-09-03 | Traditional | PDF ↗ |
| K090456 | INSUFLOW | Lexion Medical, LLC | 2009-08-26 | Traditional | PDF ↗ |
| K080852 | KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 | KARL STORZ Endoscopy-America, Inc. | 2009-03-30 | Traditional | PDF ↗ |
| K072753 | REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES | Rg Medical USA | 2008-01-25 | Traditional | PDF ↗ |
| K073452 | MODIFICATION TO: ARAGON SURGICAL LAPCAP | Aragon Surgical, Inc. | 2008-01-11 | Special | PDF ↗ |
| K070783 | SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR | Sopro | 2007-12-13 | Traditional | PDF ↗ |
| K070651 | ARAGON SURGICAL LAPCAP | Aragon Surgical, Inc. | 2007-05-30 | Traditional | PDF ↗ |
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 | W.O.M. World of Medicine AG | 2007-05-23 | Traditional | PDF ↗ |
| K063546 | INSUFLOW DEVICE, MODEL 6198 | Lexion Medical, LLC | 2007-01-10 | Special | PDF ↗ |
| K061387 | VERESURE BELL | Veresure, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K060723 | 40 L HIGH FLOW INSUFFLATOR F113 | W.O.M. World of Medicine AG | 2006-05-25 | Traditional | PDF ↗ |
| K052125 | CARBONAID GAS DIFFUSER | Cardia Innovation AB | 2006-02-08 | Traditional | PDF ↗ |
| K041560 | FLO-ASSISTANT | Northgate Technologies, Inc. | 2004-09-28 | Traditional | PDF ↗ |
| K033614 | MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 | Northgate Technologies, Inc. | 2004-07-29 | Traditional | PDF ↗ |
| K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | W.O.M. World of Medicine AG | 2004-02-05 | Traditional | PDF ↗ |
| K033991 | MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET | Pall Medical | 2004-01-22 | Special | PDF ↗ |
| K031014 | HI-FLO THERME PNEU 45, WISAP #7083, 7083V | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2003-06-27 | Traditional | PDF ↗ |
| K030469 | LAPAROSHIELD CONDITIONED INSUFFLATION SET | Pall Medical | 2003-05-09 | Traditional | PDF ↗ |
| K022052 | 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 | Northgate Technologies, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K021247 | PNEUMOPERITONEUM INSUFFLATION NEEDLE | Mectra Labs, Inc. | 2002-11-08 | Traditional | PDF ↗ |
| K022318 | VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES | Vomed Volzer Medizintechnik GmbH & Co. | 2002-09-19 | Traditional | PDF ↗ |
| K014166 | UHI-3 HIGH FLOW INSUFFLATION UNIT | Olympus Optical Co., Ltd. | 2002-06-25 | Traditional | PDF ↗ |
| K011510 | MULTI HI-FLO PNEU, WISAP #7080 | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 2002-04-02 | Traditional | PDF ↗ |
| K010053 | HUMI-FLOW, MODEL 6-850-00/ 01/02 | Northgate Technologies, Inc. | 2001-10-23 | Traditional | PDF ↗ |
| K002328 | SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR | Richard Wolf Medical Instruments Corp. | 2001-08-27 | Traditional | PDF ↗ |
| K000180 | TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP | Richard Wolf Medical Instruments Corp. | 2001-03-02 | Traditional | PDF ↗ |
| K003703 | TAUT-INSUFFLATION NEEDLE | Taut, Inc. | 2001-02-22 | Traditional | PDF ↗ |
| K003792 | STRYKER HEATED INSUFFLATOR TUBE SET | Stryker Corp. | 2001-02-21 | Traditional | PDF ↗ |
| K001533 | SURGIFLATOR-40 | W.O.M. Gmhb | 2000-07-31 | Special | PDF ↗ |
| K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | Genicon, LC | 2000-06-20 | Traditional | PDF ↗ |
| K001068 | NBS CONNECTING TUBE SET | Nbs Products CO | 2000-06-14 | Traditional | PDF ↗ |
| K000027 | INSUFFLATION NEEDLE, MODEL R65-933 | A & A Medical, Inc. | 2000-04-03 | Traditional | PDF ↗ |
| K991906 | LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT | Richard Wolf Medical Instruments Corp. | 1999-11-23 | Traditional | PDF ↗ |
| K990662 | DISPOSABLE HEATING TUBING SET #7642HSES | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1999-09-24 | Traditional | PDF ↗ |
| K992381 | CO2 GAS WARMER II, MODEL 6-800-00 | Northgate Technologies, Inc. | 1999-09-17 | Special | PDF ↗ |
| K983326 | OMNIFLATOR 7640 MODEL 7-640-00 | Northgate Technologies, Inc. | 1999-02-05 | Traditional | PDF ↗ |
| K983925 | ENDOPATH ULTRA VERESS NEEDLE | Ethicon Endo-Surgery, Inc. | 1999-02-03 | Traditional | PDF ↗ |
| K972675 | CO2 GAS WARMING UNIT (6-800-00) | Northgate Technologies, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K973447 | OMNIFLATOR 6630(6-630-00) | Northgate Technologies, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K981334 | LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) | Richard Wolf Medical Instruments Corp. | 1998-09-10 | Traditional | PDF ↗ |
| K981859 | SURGIFLATOR-20 ECU | W.O.M. World of Medicine GmbH | 1998-06-26 | Special | PDF ↗ |
| K980134 | KSEA N2O ENDOFLATOR | KARL STORZ Endoscopy-America, Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K970866 | FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER | Georgia Biomedical, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K973432 | SURGIFLATOR-30 | W.O.M. World of Medicine GmbH | 1997-12-09 | Traditional | PDF ↗ |
| K955477 | HI-TEC CO2 INSUFFLATOR TYPE 1300 | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | 1997-08-06 | Traditional | PDF ↗ |
Product code HIF · Class II · Obstetrics/Gynecology. Data: openFDA.